Medical Device Testing Services
Noble Life Sciences offers a wide range of testing GLP services to ensure both the efficacy and safety of medical devices with significant expertise in orthopaedic, cardiovascular, trauma, and wound models. We provide surgical expertise and support utilizing state of the art equipment
SERVICE OPTIONS
- GLP and non-GLP protocol development
- Prototype evaluation
- Multi-species in vivo testing
- Novel preclinical model development
- Complex surgical procedures
- Regulatory support
OPERATIONS
- FDA inspected GLP facility
- Standard operating procedures (SOP’s) that cover all aspects of animal care, animal procedures, equipment operation and facility operation
- Accredited by the Association for the Assessment and Accreditation of Laboratory Animal (AAALACi) since 1989
- Operates in full accordance with the Animal Welfare Act and the PHS Policy on Humane Care and Use of Laboratory Animals and the NRC Guide for the Care and Use of Laboratory Animals
FACILITIES
- 24,000 square feet of animal housing, support, and laboratory space securely situated in a one hundred acre campus
- 8,000 sq. ft. of conventional and 14,000 sq. ft. of specific pathogen-free (SPF) housing and support space
STAFF
- Surgeons, board-certified veterinarians, and AALAS-certified technicians with more than 15 years of medical device and GLP experience.
- Research interventionalist to help with protocol development; catheter and device placement; and basic cardiology and electrophysiology
- Quality assurance professionals over 25 years of experience
CAPABILITIES
Surgery
- Two surgical suites with recovery room, intensive care area, and preparation area
- Wide range of imaging, surgery and specialized equipment
Laboratory
- Blood collection and processing
- Necropsy, histology, pathology/ histopathology
- Clinical pathology—clinical chemistry, hematology, coagulation factor and urinalysis
Imaging
- Biophotonic imaging system for whole body, real-time in vivo imaging
- C-arm imaging scanner intensifier with radiographic capabilities fo animal imaging
- Radiography
- Computed Tomography (CT) 32 + 64 slice
- Magnetic Resonance Imaging (MRI) 1.5T + 3T scanner
- Ultrasound
MODEL OPTIONS
Cardiovascular
- Models of acute myocardial infarction (with or without reperfusion)
- Heart valve studies
- Peripheral arterial disease • Thrombosis models
- Venous/arterial grafts
- Cardiac assist devices
- Microvascular surgery
Trauma
- Critical care training for traumatic injuries
- Hemostasis
Wound Healing
- Full thickness defect
- Skin graft
- Burn models
- Diabetic models
Orthopedics
- Joint Models
- Osteoarthritis
- Arthroplasty (hip, knee) and other types of articular cartilage repair
- Anterior cruciate ligament (ACL) repair/ meniscectomy
- Artificial meniscus
- Reconstruction/fixation of other ligaments and tendons
- Artificial ligaments and tendons
- Bone Defect Models
- Osteotomy of femur, tibia and radius
- Critical size defect models in the calvarium, tibia, fibula, femur,
radius and ulna - Spinal Fusion Models
- PLIF
- PLIBF
SPECIES OPTIONS
- Small animals: mice, rats, guinea pigs, hamsters, rabbits, and ferrets
- Large animals: sheep, goats, domestic swine, mini pigs and other large animals